Do not administer Clindesse to individuals with a history of hypersensitivity to clindamycin or other lincosamides. Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme and anaphylactoid reactions. Do not administer Clindesse to patients with regional enteritis, ulcerative colitis or a history of Clostridium difficile-associated diarrhea.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases.

Vaginal intercourse or use of other vaginal products is not recommended for at least 7 days following treatment with Clindesse.

Most common adverse reactions (≥2%) of patients and at a higher rate in the Clindesse group than in the placebo group are vaginosis fungal (14%), headache (7%), back pain (5%), constipation (2%) and urinary tract infection (2%).

Note: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution and (c) contains clue cells on microscopic examination. Gram stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacilus morphology, (b) predominance of Gardnerella morphotype and (c) absent or few white blood cells.

Do not administer Clindesse to individuals with a history of hypersensitivity to clindamycin or other lincosamides. Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme and anaphylactoid reactions. Do not administer Clindesse to patients with regional enteritis, ulcerative colitis or a history of Clostridium difficile-associated diarrhea.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Vaginal intercourse or use of other vaginal products is not recommended for at least 7 days following treatment with Clindesse.

Most common adverse reactions (≥2%) of patients and at a higher rate in the Clindesse group than in the placebo group are vaginosis fungal (14%), headache (7%), back pain (5%), constipation (2%) and urinary tract infection (2%).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The information on this Web site should not take the place of talking with your doctor or healthcare professional. If you have any questions about your condition, or if you would like more information about Clindesse, talk to your doctor or pharmacist. Only you and your healthcare professional can decide if Clindesse is right for you.